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Restasis eye drop
Restasis (cyclosporine) suppresses T-cell activation and reduces inflammatory cytokine production in the lacrimal glands and ocular surface to increase tear production.
Restasis (cyclosporine) suppresses T-cell activation and reduces inflammatory cytokine production in the lacrimal glands and ocular surface to increase tear production. Used for Dry eye disease (keratoconjunctivitis sicca) to increase tear production.
At a glance
| Generic name | Restasis eye drop |
|---|---|
| Sponsor | Huons Co., Ltd. |
| Drug class | Calcineurin inhibitor |
| Target | Calcineurin (protein phosphatase 2B) |
| Modality | Small molecule |
| Therapeutic area | Ophthalmology |
| Phase | Phase 3 |
Mechanism of action
Cyclosporine is a calcineurin inhibitor that blocks T-cell proliferation and the production of pro-inflammatory cytokines (IL-2, TNF-α, IFN-γ) that contribute to dry eye disease. By reducing ocular surface inflammation, it promotes recovery of lacrimal gland function and increases tear secretion in patients with keratoconjunctivitis sicca.
Approved indications
- Dry eye disease (keratoconjunctivitis sicca) to increase tear production
Common side effects
- Ocular irritation/burning
- Conjunctival hyperemia
- Discharge
- Photophobia
Key clinical trials
- Efficacy of Vevye Ophthalmic Solution for the Treatment of Meibomian Gland Dysfunction (PHASE4)
- A Non-interventional Study to Evaluate the Anti-inflammatory Effects and the Clinical Efficacy of Topical Water Free Cyclosporin 0.1% Eye Drops in Patients With Dry Eye Disease and Associated Ocular Surface Inflammation Non-responding to Artificial Tears: the FOCUS Study (PHASE4)
- Clinical Trial To Determine The Effectiveness And Safety Of Topical Insulin In Dry Eye (PHASE4)
- Rebamipide Versus Diquafosol and Cyclosporine for Perioperative Dry Eye in Cataract Surgery (PHASE4)
- Study to Evaluate Safety and Efficacy of Cenegermin (Oxervate®) vs Vehicle in Severe Sjogren's Dry Eye Disease (PHASE3)
- Safety And Effectiveness Of The TearCare® System In The Treatment Of The Signs And Symptoms Of Dry Eye Disease (SAHARA) (NA)
- Tear Film Stability and Improvement of Asthenopia: Efficacy Observation of 0.05% Cyclosporine in Dry Eye Patients With Short BUT (NA)
- Non-interventional Study to Evaluate the Anti-inflammatory Effects and the Clinical Efficacy of Topical Water Free Cyclosporin 0.1% Eye Drops in Patients With Dry Eye Disease and Associated Ocular Surface Inflammation Non-responding to Artificial Tears
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |